Remote Investigation and Assessment of Vital Signs

Recruiting

• Conditions: Body Temperature; Oxygen Saturation; Pulse Rate; Blood Pressure; Respiratory Rate
• Interventions: Diagnostic Test: RIA-VS

• Registration Number: NCT05022264
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure.

This project aims to evaluate a new camera-based system for contactless measurement of vital signs.

Detailed Description

STUDY DESIGN:

A method comparison design with three work packages (WP):

WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.

WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).

WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.

STUDY POPULATION:

WP1: Patients aged ≥18 years admitted to or attending a hospital clinic. WP2: Patients aged ≥18 year attending primary health care or patients being admitted to a hospital clinic.

WP3: Individuals aged ≥18 years attending primary health care.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-26
• Study Start: 2022-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP2.

WP1+WP2:

1. The patient is attending primary or secondary health care.
2. The subject has provided informed consent.
3. Age ≥18 years.
4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
5. The patient is willing and able to give informed consent ".
6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
7. The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

WP3:

1. Patients attending primary health care.
2. The subject has provided informed consent.
3. Age ≥18 years.
4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
5. The patient is willing and able to give informed consent .
6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
7. The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

Exclusion Criteria

Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	RIA-VS	All participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS)

Primary Outcome Measures

Name	Time	Method
Agreement between conventional techniques and the new RIA-VS device	The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes	Estimate the agreement between vital signs estimated with the new RIA-VS study device and vital signs estimated using traditional techniques (the criterion validity). Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: a) Validity of the new method: The gold standard will be the mean between the two reference methods. The first measurement of the new RIA-VS device will be the new method compared with the gold standard using a Bland-Altman plot. We will also produce simple scatter plots comparing the gold standard with the new RIA-VS device for illustration.

Secondary Outcome Measures

Name	Time	Method
Estimate test-retest reliability of the new RIA-VS device	The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes	Estimate the new RIA-VS study device test-retest reliability and to compare this with the test-retest reliability of the reference method. Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: 1. Test-retest reliability of the new RIA-VS method: The difference between the two tests will be plotted on the Y-axis and the mean value of the two estimates of the new RIA-VS device on the x-axis in a modified Bland-Altman plot.; 2. Comparison of the random variability: The variance of the difference between the two measures using the reference method will be compared with the variance from the difference between the two RIA-VS estimates. This enables comparing the random variability of both the reference method as well as the new RIA-VS device.
Evaluate the influence of different skin types on the validity of the new RIA-VS study device	The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes	Investigate if different Fitzpatrick skin types influences the validity of the new RIA-VS study device. We will use the definition of skin types as described in: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;124(6):869-71).; The statistics described in the primary outcome measure and the first secondary outcome measure (test-retest reliability) will be made separately for patients with Fitzpatrick skin color type 0-4 as well as type 5-6 to see if skin color influences readings with the new RIA-VS device.

Trial Locations

Locations (1)

Hälsobrunnen Vårdcentral; 🇸🇪 Ulricehamn, Sweden